Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele

Completed

• Conditions: Urodynamic Stress Incontinence in Severe Cystocele Women
• Interventions: Diagnostic Test: Urodynamic study

• Registration Number: NCT03613311
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

Prevalence rates of urodynamic urinary incontinence (USI) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation, especially for occult USI. Misdiagnosis of occult USI before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Detailed Description

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. The recruited patients with cystocele were classified into three groups (i.e.,evident USI, occult USI and no demonstrated USI) according to pad weight results before and after prolapse reduction.

Study Timeline

• Study Start: 2011-11-01
• Primary Completion: 2017-01-31
• Study Completion: 2018-05-31
• Status Verified: 2018-07
• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-01
• Last Update Submitted: 2018-08-01
• Study First Posted: 2018-08-03
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 480

Inclusion Criteria

1. Age >20y/o
2. Cystocele > stage II
3. Complete urodynamic study

Exclusion Criteria

1. Pregnancy
2. Urinary tract infection
3. Previous pelvic reconstruction surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Occult USI	Urodynamic study	Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction after prolapse reduction by vaginal gauze.
Evident urodynamic stress incontinence(USI)	Urodynamic study	Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction.
ND USI	Urodynamic study	Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. No USI was noted in this group.

Primary Outcome Measures

Name	Time	Method
Evident USI	Between November 2011 and January 2017	USI note before reduction of prolapse
Occult USI	Between November 2011 and January 2017	USI note after reduction of prolapse